cyproterone + ethinylestradiol




Four Star
Concise Prescribing Info
Ethinyl estradiol 0.035 mg, cyproterone acetate 2 mg
Moderate to severe acne due to androgen sensitivity (w/ or w/o seborrhoea) &/or hirsutism in women of childbearing age, after failure of topical or systemic antibiotic therapy. Hormonal contraceptive in women w/ androgen-dependent conditions.
Dosage/Direction for Use
1 tab daily taken at about same time each day for 21 consecutive days, followed by a tab-free interval of 7 days.
May be taken with or without food.
Hypersensitivity. Existing or previous venous thrombosis (eg, DVT, pulmonary embolism); personal or family medical history of known, idiopathic venous thromboembolism (VTE); existing or previous arterial thrombosis (eg, MI) or previous disorders (eg, angina pectoris, & transient ischemic attack); existing or previous CVA; presence of severe or multiple risk factors for venous or arterial thrombosis; inherited or acquired predisposition for venous or arterial thrombosis; sickle cell anemia; pancreatitis or a history thereof if associated w/ severe hypertriglyceridaemia &/or other disturbances in lipid metabolism; severe hepatic disorders (also disorders of the excretory system eg, Dubin-Johnson & Rotor syndrome); presence or history of liver tumors; undiagnosed vag bleeding; history of migraine w/ focal neurological symptoms; smokers; known or suspected sex steroid-influenced malignancies; history of idiopathic jaundice & severe pruritus (herpes gestationis) of pregnancy; otosclerosis worsening w/ each pregnancy. Women w/ thrombophlebitis, thromboembolic disorders, or history of these conditions. Concomitant use of another hormonal contraceptive. Not for use in men. Pregnancy & lactation.
Special Precautions
Increased risk of VTE, arterial thromboembolism (eg, MI, transient ischemic attack), or CVA; cervical cancer. Increased frequency or severity of migraine. Include liver tumor in differential diagnosis in case of non-specific upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage. Rare genetic galactose or fructose intolerance, lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase deficiency. May only be used after menarche. Not indicated after menopause.
Adverse Reactions
Nausea, abdominal pain; wt increase; headache; depressive mood, mood altered; breast pain & tenseness, intermenstrual bleeding.
Drug Interactions
Altered metabolism w/ barbiturates, rifampicin, antiepileptic drugs (eg, barbexaclone, carbamazepine, phenytoin, primidone), oxcarbazepine, topiramate, felbamate, griseofulvin, products containing St. John's wort (Hypericum perforatum); HIV PIs (eg, ritonavir), NNRTIs (eg, nevirapine). Increased plasma & tissue conc of cyclosporin. Decreased plasma & tissue conc of lamotrigine. Reduced levels w/ antibiotics (eg, penicillins & tetracyclines). Requirement for antidiabetics may change.
MIMS Class
Acne Treatment Preparations / Oral Contraceptives
ATC Classification
G03HB01 - cyproterone and estrogen ; Belongs to the class of antiandrogen preparations in combination with estrogens. Used to counter androgenic activities.
Diane-35 tab
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